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510(k) Data Aggregation

    K Number
    K172508
    Device Name
    Ageless Health Medical Digital Thermometer
    Manufacturer
    Ageless Health Industrial Co., Ltd
    Date Cleared
    2018-08-08

    (352 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ageless Health Industrial Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ageless Health Medical Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. lt can be used for axillary measurement, oral measurement and rectal measurement.
    Device Description
    Ageless Health Medical Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermos sensor and ASIC technology. A thermistor is used as thermos sensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD.
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    K Number
    K172895
    Device Name
    AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819
    Manufacturer
    Ageless Health Industrial Co., Ltd
    Date Cleared
    2018-06-18

    (269 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ageless Health Industrial Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.
    Device Description
    AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
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    K Number
    K153552
    Device Name
    AGE Automatic Upper Arm Blood Pressure Monitor
    Manufacturer
    Ageless Health Industrial Co., Ltd
    Date Cleared
    2016-06-01

    (173 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ageless Health Industrial Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is six sizes. AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
    Device Description
    AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
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    K Number
    K152508
    Device Name
    Ageless Health Medical Digital Thermometer
    Manufacturer
    DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
    Date Cleared
    2015-12-31

    (120 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    DONGGUAN AGELESS HEALTH INDUSTRIAL CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral).
    Device Description
    Ageless Health Medical Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermosensor and ASIC technology. A thermistor is used as thermosensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD.
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    K Number
    K151281
    Device Name
    AGE Automatic Wrist Blood Pressure Monitor
    Manufacturer
    DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD
    Date Cleared
    2015-06-30

    (47 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    DONGGUAN AGELESS HEALTH INDUSTRIAL CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AGE Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 13.5cm~19.5cm.
    Device Description
    AGE Automatic Wrist Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist within its claimed range and accuracy via the Oscillometry technique. The device also has low voltage indication, which will be triggered when the battery is low.
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    K Number
    K123882
    Device Name
    AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR
    Manufacturer
    AGELESS HEALTH INDUSTRIAL
    Date Cleared
    2013-08-14

    (240 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    AGELESS HEALTH INDUSTRIAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AGE Automatic Upper Arm Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 24~34 cm.
    Device Description
    AGE Automatic Upper Arm Blood Pressure Monitor is a battery driven automatic non-invasive blood pressure meter. It can automatically conduct the inflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at arm within its claimed range and accuracy via the oscillometric technique. The device also has low voltage indication, which will be triggered when the battery is low.
    Ask a Question

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